Apparatus and methods for providing tactile feedback while delivering a closure device

ABSTRACT

An apparatus for sealing a passage through tissue includes a tubular member, a plug, and a locator member. The plug is disposed on a distal end of the tubular member and includes an external thread. The locator member is inserted into a lumen of the tubular member until a distal portion is disposed beyond the plug. The distal portion includes a helically wound wire and a tether coupled to the wire that is movable for causing the wire to buckle. To seal a passage communicating with a blood vessel, the distal portion of the locator member is inserted into the passage, and the plug is threaded into the passage until the distal portion extends into the vessel. The tether is pulled to buckle the wire, and the plug is unthreaded until the buckled wire contacts a wall of the vessel, whereupon the plug is released to seal the passage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation application of U.S. patent application Ser. No.10/006,400, filed Nov. 30, 2001, now U.S. Pat. No. 7,842,068, andentitled “Apparatus and Methods for Providing Tactile Feedback WhileDelivering a Closure Device”, which is a continuation-in-part of U.S.patent application Ser. No. 09/732,835, filed Dec. 7, 2000, now U.S.Pat. No. 6,780,197 the disclosures of which are each incorporated hereinby this reference.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forsealing or closing passages through tissue, particularly to devices fordelivering a closure device within a passage communicating with a bodylumen, such as a blood vessel, and more particularly to apparatus andmethods for positioning such a device relative to the body lumen beforedelivery.

BACKGROUND OF THE INVENTION

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and muscle tissue into the vascular system. A guide wiremay then be passed through the needle lumen into the patient's bloodvessel accessed by the needle. The needle may be removed, and anintroducer sheath may be advanced over the guide wire into the vessel,e.g., in conjunction with or subsequent to a dilator. A catheter orother device may then be advanced through a lumen of the introducersheath and over the guide wire into a position for performing a medicalprocedure. Thus, the introducer sheath may facilitate introduction ofvarious devices into the vessel, while minimizing trauma to the vesselwall and/or minimizing blood loss during a procedure.

Upon completion of the procedure, the devices and introducer sheath maybe removed, leaving a puncture site in the vessel wall. Externalpressure may be applied to the puncture site until clotting and woundsealing occur. This procedure, however, may be time consuming andexpensive, requiring as much as an hour of a physician's or nurse'stime. It is also uncomfortable for the patient, and requires that thepatient remain immobilized in the operating room, catheter lab, orholding area. In addition, a risk of hematoma exists from bleedingbefore hemostasis occurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the useof a biodegradable plug that may be delivered through an introducersheath into a puncture site. When deployed, the plug may seal the vesseland provide hemostasis. Such devices, however, may be difficult toposition properly with respect to the vessel, which may be particularlysignificant since it is generally undesirable to expose the plugmaterial, e.g., collagen, within the bloodstream, where it may floatdownstream and risk causing an embolism.

Another technique has been suggested that involves percutaneouslysuturing the puncture site, such as that disclosed in U.S. Pat. No.5,304,184, issued to Hathaway et al. Percutaneous suturing devices,however, may require significant skill by the user, and may bemechanically complex and expensive to manufacture.

Staples and surgical clips have also been suggested for closing woundsor other openings in tissue. For example, U.S. Pat. Nos. 5,007,921 and5,026,390, issued to Brown, disclose staples that may be used to close awound or incision.

In addition, skin seals have been proposed that may be threaded into anopening in skin. For example, U.S. Pat. No. 5,645,565, issued to Rudd etal., discloses a surgical plug that may be screwed into a puncture toseal the puncture. The surgical plug includes an enlarged cap and athreaded shaft that extends from the cap. During an endoscopicprocedure, the plug may be threaded into an opening through skin untilthe cap engages the surface of the skin. The plug is intended to sealthe opening communicating with a body cavity to prevent insufflationfluid from leaking from the cavity. Such plugs, however, may only beused at the surface of the skin, and may not be introduced throughtissue, for example, to seal an opening in the wall of a blood vessel orother subcutaneous region.

To facilitate positioning devices that are percutaneously inserted intoa blood vessel, “bleed back” indicators have been suggested. Forexample, U.S. Pat. No. 4,317,445, issued to Robinson, discloses aflashback chamber on a first end of a cannula that communicates with aport on a second end. The second end is percutaneously introduced into apatient until the port enters the vessel, whereupon blood, under normalblood pressure, may advance along the cannula and enter the flashbackchamber, thereby providing a visual indication that the vessel has beenentered. This reference, however, does not discuss vascular woundclosure, but is merely directed to an introducer device. In contrast,U.S. Pat. No. 5,676,974, issued to Kensey et al., discloses a bleed backlumen intended to facilitate positioning of a biodegradable plug withina puncture site. This device, however, requires that an anchor of theplug be positioned within the vessel, and therefore, may increase therisk of over-advancement of the plug itself into the vessel.

Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al.,discloses a deployable loop that may be advanced through a sheath into avessel. The loop is intended to resiliently expand to engage the innerwall of the vessel, thereby facilitating holding the sheath in a desiredlocation with respect to the vessel. The loop may also provide a supportfor facilitating the deployment and deflection of a surgical clipagainst the vessel wall. Such a device, however, may risk engagementbetween the loop and the surgical clip, thereby preventing the loop frombeing withdrawn from the vessel.

Accordingly, apparatus and methods for delivering devices for sealingpunctures or other passages through tissue communicating with a bloodvessel would be considered useful.

BRIEF SUMMARY

The present invention is directed to apparatus and methods fordelivering devices for sealing or closing passages through tissue, suchas punctures communicating with blood vessels or other body lumens, and,more particularly, to apparatus and methods for positioning such devicesrelative to the body lumens before delivery.

In accordance with one aspect of the present invention, an apparatus isprovided for positioning a closure device within a passage throughtissue communicating with a body lumen. The apparatus includes anelongate member, e.g., an introducer sheath or other tubular member,including a proximal end, a distal end, and a lumen extending betweenthe proximal and distal ends defining a longitudinal axis.

A closure element is associated with the elongate member for sealing thepassage. In a preferred embodiment, the closure element is a plug memberdisposed on the distal end of the elongate member. The plug member mayinclude a thread pattern on its outer surface, and may include a distalport communicating with a passage therethrough that, in turn,communicates with the lumen in the handle device. A sealing member maybe provided in the passage for substantially sealing the passage fromfluid flow therethrough. The plug member is preferably releasablyattached to the distal end of the elongate member, e.g., by one or moreconnectors on the distal end of the elongate member and/or on the plugmember. Alternatively, the closure element may be a clip that isdeployable from the elongate member, e.g., from a housing slidablydisposed on the elongate member.

A locator member is provided that may be inserted through the lumen, thelocator member having a distal portion that extends distally beyond thedistal end of the elongate member when the locator member is fullyinserted into the lumen. If the closure element is a plug member, thedistal portion also extends beyond the plug member, e.g., through thepassage therein.

The locator member includes an elongate deflectable element including aproximal end and a distal end, and a control element coupled to thedistal end of the deflectable element. The control element is movableproximally for causing an intermediate portion of the deflectableelement, e.g., the distal portion of the locator member, to bucklesubstantially transversely with respect to the longitudinal axis. In apreferred embodiment, the deflectable element is a helically wound wireand the control member is a tether extending along at least theintermediate portion of the helically wound wire. The tether may extendwithin the helically wound wire and/or along an outer surface of atleast a portion of the helically wound wire. Preferably, theintermediate portion of the deflectable element has a cross-section inits buckled configuration that is larger than a cross-section of thelumen, thereby preventing the deflectable element from being withdrawninto the plug member and/or elongate member once activated.

In accordance with another aspect of the present invention, a method isprovided for sealing a passage communicating with a body lumen using anapparatus, such as that described above. The apparatus generallyincludes an elongate member including proximal and distal ends, and aclosure element deployable from the distal end of the elongate member.

A locator member is coupled to the elongate member such that a distalportion of the locator member extends beyond the distal end of thetubular member. For example, if the elongate member is an introducersheath or other tubular member including a lumen, the locator member maybe inserted into the lumen. The distal end of the elongate member isadvanced through a patient's skin towards the body lumen via the passageuntil the distal portion of the locator member is located within thebody lumen. For example, if the closure element is a plug member, theelongate member may be rotated to thread the plug member into thepassage towards the body lumen.

A deflectable element on the distal portion of the locator member isbuckled from an axial collapsed configuration to a transverse expandedconfiguration. The elongate member is manipulated such that the buckleddistal portion engages or otherwise contacts a proximal wall of the bodylumen, thereby providing a tactile indication of the location of thedistal end of the elongate member relative to the body lumen.

The closure device is then deployed from the distal end of the elongatemember within the passage. The elongate member and the locator memberare then withdrawn from the passage, leaving the closure element tosubstantially seal the opening.

Preferably, the deflectable element of the locator member includes ahelically wound wire, and a tether or other control member coupled to adistal end of the helically wound wire. The tether may be subjected totension, e.g., directed proximally, to buckle the helically wound wiresubstantially transversely, thereby defining the transverseconfiguration.

In a preferred embodiment, the closure element is a plug memberreleasably coupled to the distal end of the elongate member andincluding an external thread pattern. If the elongate member is atubular member, the plug member may include a distal port communicatingwith the lumen in the tubular member, such that the locator member maybe inserted into the tubular member until the distal portion extendsthrough the distal port of the plug member. The distal portion isinserted into the passage until the plug member enters the passage,whereupon the plug member is threaded into the passage until the distalportion of the locator member enters the body lumen. The distal portionmay be activated, as described above, and used to provide tactilefeedback to position the plug member. For example, the plug member maybe at least partially unthreaded before the plug member is deployedwithin the passage.

In an alternative embodiment, the apparatus may be used in conjunctionwith an introducer sheath or other tubular member already in placewithin the passage, e.g., that is used to access the body lumen during aprocedure. The locator member may be inserted through the tubular memberuntil the distal portion of the locator member is located within thebody lumen. The deflectable element on the distal portion of the locatormember may be buckled from an axial collapsed configuration to atransverse expanded configuration. The locator member may bemanipulated, e.g., pulled proximally, such that the buckled distalportion engages or otherwise contacts a proximal wall of the body lumen,thereby providing a tactile indication that the distal portion isdisposed within the body lumen and/or limiting further proximal movementof the locator member.

A plug member (or other closure device) may then be advanced over thelocator member into the passage. For example, the plug member, disposedon the distal end of an elongate member, may be threaded through thetissue along the passage over the locator member. Preferably, thelocator member is inserted through the distal port of the plug memberand/or through the lumen of the elongate member as the plug member isadvanced. Once the plug member attains a desired location within thepassage, the plug member may be released from the distal end of theelongate member within the passage. The distal portion of the locatormember may be returned to its axial configuration, and the elongatemember and the locator member may be withdrawn from the passage, leavingthe plug member to substantially seal the opening.

To facilitate positioning of the plug member, the locator member mayinclude one or more markers, e.g., disposed on a proximal portion, thatmay have a predetermined relation with the distal portion of the locatormember. For example, the proximal portion of the locator member mayinclude a marker band located a predetermined distance from the distalportion. The elongate member may include a window for observing themarker when the plug member reaches a predetermined location relativethe distal portion, e.g., a predetermined distance proximal to thedistal portion. Alternatively, the locator member and the elongatemember may include cooperate tactile elements, e.g., tabs and pockets,that engage one another when the plug member reaches a predeterminedlocation. The plug member may then be released at the predeterminedlocation, and then the elongate member and locator member may beremoved.

Other objects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an apparatus for delivering a closure element,including an introducer sheath, a locator, and an actuator assembly, inaccordance with the present invention.

FIG. 2 is a side view of the apparatus of FIG. 1, with the locatordisposed within the sheath, and a housing on the sheath advanced to adelivery position.

FIGS. 3A and 3B are perspective views of the distal end of the apparatusof FIGS. 1 and 2, showing positioning elements on the locator incollapsed and expanded configurations, respectively.

FIGS. 4A-4F are cross-sectional views of a blood vessel, showing amethod for delivering a closure device into a passage communicating withthe vessel.

FIG. 5 is a cross-sectional view of the blood vessel of FIG. 4D, showingthe positioning elements engaging a wall of the vessel.

FIG. 6 is a perspective view of an alternate embodiment of a distalportion of the locator with the positioning elements disposed in theirexpanded configuration.

FIGS. 7A and 7B are side views of another embodiment of a distal portionof a locator with positioning elements disposed in collapsed andexpanded configurations, respectively.

FIGS. 8A and 8B are side views of the locator of FIGS. 7A and 7B,including a control on the locator for adjusting the expansion of thepositioning elements.

FIG. 9 is a cross-section view of a distal portion of an alternativeembodiment of an apparatus for delivering a closure element, inaccordance with the present invention.

FIG. 10 is a cross-sectional view of a distal portion of yet anotheralternative embodiment of an apparatus for delivering a closure element,in accordance with the present invention.

FIGS. 11A and 11B are side views of another preferred embodiment of alocator device, in accordance with the present invention.

FIG. 12A is an exploded perspective view of an apparatus for deliveringa closure device, including the locator device of FIGS. 11A and 11B.

FIG. 12B is a perspective view of the apparatus of FIG. 12A afterassembly, and with the locator device deployed.

FIGS. 13A-13D are cross-sectional side views, showing a method fordelivering a plug member using the apparatus of FIGS. 12A and 12B.

FIG. 14 is a detail of FIG. 13C, showing activation of the locatormember with a blood vessel.

FIGS. 15A-15D are cross-sectional side views, showing another method fordelivering a plug member using the apparatus of FIGS. 12A and 12B.

DETAILED DESCRIPTION

Turning now to the drawings, FIGS. 1-2 show a first preferred embodimentof an apparatus 10 for providing access into a blood vessel or otherbody lumen from an incision, puncture, or other passage (not shown inFIGS. 1 and 2), and/or for delivering a closure element, such as clip 26(shown in phantom), for closing the passage. Generally, the apparatus 10includes an introducer sheath 12, a housing 24 slidably disposed on thesheath 12, a locator member 14 insertable into the sheath 12, and anhousing actuator assembly 30.

The sheath 12 includes a substantially flexible or semi-rigid tubularbody 15 including a lumen 16 extending between its proximal and distalends 18, 20. The distal end 20 has a size and shape to facilitateinsertion into a blood vessel, e.g., having a tapered tip 22 forfacilitating substantially atraumatic introduction through the passageand at least partially into the vessel. The lumen 16 has a size foraccommodating insertion of one or more devices therethrough, such as acatheter, guidewire, and the like (not shown). The sheath 12 alsopreferably includes a seal (not shown), such as a hemostatic valve,within the lumen 16 at or near the proximal end 18 that provides afluid-tight seal, yet accommodates insertion of one or more devices,such as the locator 14, into the lumen 16 without fluid passingproximally from the sheath 12.

Optionally, the sheath 12 may include a side port 19 that communicateswith the lumen 16, for example, to allow the infusion of fluids into thelumen 16, through the sheath 12. Alternatively, or in addition, the sideport 19 may be used to provide a “bleed back” indicator, such as thatdisclosed in co-pending application Ser. No. 09/680,837, filed Oct. 6,2000, entitled “Apparatus and Methods for Positioning a VascularSheath,” which is assigned to the assignee of the present invention. Thedisclosure of this application and any references cited therein areexpressly incorporated herein.

A housing 24 is slidably disposed on an exterior of the sheath 12, thehousing 24 configured for releasably holding the closure element 26. Thehousing 24 may include an ejector or other mechanism (not shown) fordeploying the closure element 26 from the housing 24. In a preferredembodiment, the closure element 26 is an annular-shaped clip, includingone or more barbs 28 for engaging the tissue around the punctureadjacent to the wall of the vessel. Preferably, the clip 26 isconfigured for drawing the tissue around the puncture at the wall of thevessel substantially closed and/or for enhancing hemostasis within thepuncture. Exemplary embodiments of a housing and closure element for usewith an apparatus in accordance with the present invention are disclosedin co-pending application Ser. Nos. 09/478,179, 09/546,998, and09/610,238, the disclosures of which are expressly incorporated hereinby reference.

The housing 24 is actuable from the proximal end 18 of the sheath 12(FIG. 1), for example, by housing actuator assembly 30, for advancingthe closure element 26 distally during deployment. The housing 24 may besubstantially permanently but slidably disposed on the sheath 12. Inthis embodiment, the housing actuator assembly 30 may be substantiallypermanently attached to the proximal end 18 of the sheath 12. Thehousing 24 may be coupled to the housing actuator assembly 30 such thatthe housing 24 may be directed axially along the exterior of the sheath.

Alternatively, the housing 24 may be provided separate from the sheath12 (not shown), e.g., with the closure element 26 pre-loaded therein. Inthis embodiment, the housing actuator assembly 30 may also be providedseparate from the sheath 12, as shown, either coupled to or separatefrom the housing 24. Any time before delivering the closure element 26,the housing 24 may be directed over the sheath 12, e.g., by insertingthe proximal end 18 of the sheath 12. The housing actuator assembly 30may be attached to the proximal end 18 of the sheath 12, e.g., bycooperating connectors (not shown). The housing 24 may be coupled to thehousing actuator assembly 30, if not already attached, thereby preparingthe housing 24 for use.

In a preferred embodiment shown in FIGS. 1 and 2, the housing actuatorassembly 30 includes first and second actuator members 46, 48 that aregenerally movable with respect to one another. The first actuator member46 may be connected to the proximal end 18 of the sheath 12, forexample, by rods (not shown) such that the first member 46 issubstantially fixed with respect to the sheath 12. A rod, cable, orother control wire 44 is coupled to and extends generally proximallyfrom the housing 24. The control wire 44 may extend along an outersurface of the sheath 12, as shown, or alternatively may extend througha lumen (not shown) in the sheath 12 beyond the proximal end 18.

A loose end 50 of the control wire 46 may be coupled to the secondactuator member 48. For example, the housing actuator assembly 30 may beadvanced over the control wire 46 such that the loose end 50 passesthrough aperture 52 in the first member 46 and is received in a matingpocket 54 in the second member 48, as best seen in FIG. 2. The loose end50 may be frictionally engaged within the pocket 54 or, alternatively,the loose end 50 and pocket 54 may include cooperating detents (notshown) for securing the control wire 44 to the second actuator member48.

The second actuator member 48 may be movable with respect to the firstactuator member 46 by one or more rods or rails (not shown) extendingtherebetween. Thus, the second actuator member 48 may be movable from afirst or proximal position (not shown), located a first distance fromthe first actuator member 46, distally to a second or distal position(shown in FIG. 2), located a second closer distance from the firstactuator member 46. When the housing actuator assembly 30 is attached tothe sheath 12 with the control wire 44 coupled to the second actuatormember 48, the housing 24 may be directed from a proximal position(e.g., shown in FIG. 1) to a distal or delivery position (e.g., shown inFIG. 2) when the second actuator member 48 is moved from its proximalposition to its distal position.

In a preferred embodiment, the second actuator member 48 is biased toits distal position, for example, by spring 56 or other biasing element.The second actuator member 48 may be locked in its proximal position,for example, by a locking mechanism (not shown), thereby retaining thehousing 24 in its proximal position. When it is desired to advance thehousing 24, a button, switch, or other activation member (not shown) maybe deployed to release the locking mechanism, thereby automaticallydirecting the second actuator member 48 towards the first actuatormember 46, and thereby advancing the housing 24 to its distal position,as described further below. The closure element 26 may be automaticallyejected from the housing 24 once it reaches the distal position or theclosure element 26 may be subsequently ejected by a separate action. Itwill be appreciated by those skilled in the art that other housingactuator configurations may be provided for advancing the housing 24with respect to the sheath 12, e.g., to deliver the closure element 26.

The housing actuator assembly 30 may also include an adjustmentmechanism, such as threaded bolt or knob 58. For example, the knob 58may be provided on the first actuator member 46 such that, as the knob58 is rotated, the first actuator member 46 may be moved axially withrespect to the sheath 12. Because the first actuator member 46 may beadjusted distally or proximally with respect to the sheath 12, thedistal position of the second actuator member 48 consequently may beadjusted. This, in turn, may facilitate adjusting the distal position ofthe housing 24, e.g., to compensate for the thickness of a particularwall of a blood vessel when a closure element 26 is delivered to close apuncture in the wall.

Turning to FIGS. 1, 2, 3A, and 3B, the locator member 14 includes aflexible or semi-rigid tubular body or other elongate rail 32 having aproximal end 34 and a distal end 36. An actuator rod or other elongatemember 38 is slidably disposed with respect to the rail 32, e.g., withina lumen 33 of tubular body 32. Preferably, the locator member 14includes an annular ridge 40 or other detent on or near its proximal end40 that may engage a complementary-shaped pocket 42 or other cooperatingdetent on the sheath 12. Thus, the locator member 14 may besubstantially secured axially with respect to the sheath 12.

As best seen in FIGS. 3A and 3B, a distal portion 60 of the locatormember 14 includes a substantially rounded, soft, and/or flexible distaltip 62, possibly including a pigtail (not shown) that may facilitateatraumatic advancement of the distal portion 60 into a blood vessel orother body lumen. The locator member 14 preferably has a length relativeto the sheath 12 such that the distal portion 60 extends beyond thedistal end 20 of the sheath 12 when the locator member 14 is fullyreceived therein, as shown in FIG. 2.

One or more, and preferably a plurality of, positioning elements 64 areprovided on the distal portion 60 that may be selectively expandablebetween a substantially axial collapsed configuration (shown in FIG. 3A)and a substantially transverse expanded configuration (shown in FIG.3B). Preferably, the positioning elements 64 are substantially flexiblesplines configured for expanding substantially transversely with respectto a longitudinal axis 13 of the apparatus 10. In one embodiment, shownin FIGS. 1 and 2, the locator member 14 includes a pair of splines 64disposed generally opposite one another about the distal portion 60.Alternatively, as shown in FIG. 6, the locator member 14 may includefour splines 64′ that are substantially equally spaced about the distalportion 60. The locator member 14 may include more or fewer splineswithout deviating from the scope of the present invention.

Optionally, the splines 64 may include radiopaque markers (not shown) ormay be at least partially formed from radiopaque material to facilitateobservation of the splines 64 using fluoroscopy or other imagingsystems. In addition, the housing 24 may include a radiopaque marker,e.g., at its distal end (not shown) and/or the closure element 26 mayinclude a radiopaque marker or may be made from radiopaque material.This may facilitate monitoring the relative location of the closureelement 26 to the splines 64, as described further below.

Returning to FIGS. 3A and 3B, each spline 64 preferably has a firstfixed (e.g., proximal) end 64 a and a second movable (e.g., distal) end64 b. The second end 64 b may be axially movable towards the first end64 a to cause an intermediate region 64 c of the spline 64 to expandtransversely outward, thereby defining the substantially transverseexpanded configuration. In a preferred embodiment, actuator rod 38extends through the distal portion 60 and is coupled to the second end64 b of the splines 64 and/or to distal tip 62 of the locator member 14.The rod 38 may be moved axially, e.g., proximally, with respect to therail 32 to selectively expand the splines 64 between their collapsedconfiguration and their expanded configuration.

A locator actuator 70 may be coupled to the locator member 14, thelocator actuator 70 configured for selectively expanding the splines 64from their collapsed configuration to their expanded configuration. Forexample, the locator actuator 70 may include a switch 72 that may bedepressed or rotated to retract or move the rod 38 proximally, therebyexpanding or deploying the splines 64. The locator actuator 70preferably includes a lock (not shown) for securing the rod 38 in aproximal position and thereby locking the splines 64 in their expandedconfiguration. The lock may be released, for example, by depressing theswitch 72. The locator actuator 70 may include a spring 74 or otherbiasing mechanism for biasing the rod 38 distally, e.g., to return thesplines 64 to their collapsed configuration when the lock is released.For example, as described further below, the lock may be released uponactivation of the housing actuator assembly 30, e.g., when the secondactuator member 48 moves towards its distal position.

Turning to FIGS. 4A-4F, the apparatus 10 may be used to provide accessinto a blood vessel or other body lumen 90. Preferably, the apparatus 10may be used to deliver a closure device, such as clip 26, to closeand/or seal an incision, puncture, or other passage 92 that extends froma patient's skin 94 through intervening tissue 96, and a wall 98 of thevessel 90.

As shown in FIG. 4A, the sheath 12, without the locator member 14therein, may be inserted or otherwise positioned within the blood vessel90, i.e., through the passage 92. The sheath 12 is preferably providedwith the housing 24 in its proximal position, without the housingactuator assembly (not shown) attached. Alternatively, the housingactuator assembly may be provided attached to the sheath 12 as long asthe lumen 16 may be accessed. In a further alternative, the sheath 12may be provided without the housing 24 thereon. The sheath 12 may beadvanced over a guide wire or other rail (not shown) previouslypositioned through the passage 92 into the blood vessel 90 using aconventional procedure. Preferably, the blood vessel 90 is a peripheralvessel, such as a femoral or carotid artery, although other body lumensmay be accessed using the sheath 12, as will be appreciated by thoseskilled in the art.

The passage 92, and consequently the sheath 12, may be oriented at asubstantially acute angle “alpha” with respect to the vessel 90, therebyfacilitating introduction of devices through the lumen 16 of the sheath12 into the vessel 90 with minimal risk of damage to the vessel 90. Oneor more devices, such as a guide wire, a catheter, and the like (notshown), may be inserted through the sheath 12 and advanced to a desiredlocation within the patient's body. For example, the devices may be usedto perform a therapeutic or diagnostic procedure, such as angioplasty,atherectomy, stent implantation, and the like, within the patient'svasculature.

After the procedure is complete, the device(s) may be removed from thesheath 12, and the locator member 14 may be inserted through thehemostatic valve (not shown) into the lumen 16. If the housing 24 is notalready provided on the sheath 12, the housing 24 and/or the housingactuator assembly (not shown) may be advanced over or otherwise attachedto the proximal end of the sheath 12, preferably before the locatormember 14 is inserted into the sheath 12.

As shown in FIG. 4B, when the locator member 14 is fully inserted withinthe sheath 12, the distal portion 60 extends beyond the distal end 20 ofthe sheath 12. In an alternative embodiment, the locator member 14 maybe attached to an exterior surface (not shown) of the sheath 12, forexample, along a track, e.g., cooperating slots, grooves, and the like(not shown) in the sheath 12 and locator member 14. The distal tip 62preferably is substantially soft and/or flexible such that the distalportion 60 substantially atraumatically enters the vessel 90. In thisfully inserted position, cooperating detents (not shown) may be engagedto substantially secure the locator member 14 axially with respect tothe sheath 12. The housing actuator assembly (not shown) may be attachedto the sheath 12, e.g., by attaching a control wire (not shown) from thehousing 24 to the actuator assembly, as described above.

Alternatively, the sheath 12 may include a side port (not shown) at ornear its distal end 20 and a bleed back lumen (also not shown) thatextends from the side port to the proximal end of the sheath 12. Beforeor after insertion of the locator member 14, the sheath 12 may bemanipulated until “bleed back” (i.e., blood entering the side port andpassing proximally through the lumen due to exposure of the side port toblood pressure within the vessel) indicates a desired position for thedistal end 20 of the sheath 12. For example, the sheath 12 may bepartially withdrawn from the vessel 90 before the locator member 14 isinserted into the sheath 12 to minimize contact between the vessel wall98 and the distal portion 60 of the locator member 14 during insertionof the locator member 14 into the sheath 12.

As shown in FIG. 4C, the splines 64 may then be directed to theirexpanded configuration, for example, by activating a switch on theproximal end (not shown) of the locator member 14. The sheath 12 andlocator member 14 may then be moved in conjunction with one another, andpreferably are together partially withdrawn from the vessel 90, untilthe splines 64 contact the wall 98 of the vessel 90, as shown in FIG.4D. Thus, the splines 64 may provide a tactile indication of theposition of the sheath 12 with respect to the wall 98 of the vessel 90.In addition, the splines 64 may assist in “presenting” the wall 98 ofthe vessel 90, e.g., for receiving a closure element, such as clip 26.

Turning to FIG. 4E, with the sheath 12 properly positioned, the housing24 may then be actuated, for example, to advance the housing 24 distallyinto the passage 92 to deliver the clip 26. Preferably, movement of thehousing 24 with respect to the distal end 20 of the sheath 12 islimited, e.g., by the housing actuator assembly (not shown), asdescribed above. Preferably, the housing 24 may only be advanced a fixeddistance such that the clip 26 substantially engages the wall 98 of theblood vessel, e.g., until the barbs 28 penetrate but do not passcompletely through the wall 98. Thus, with the splines 64 fixed withrespect to the distal end 20 of the sheath 12 and the distal position ofthe housing 24 fixed, the clip 26 may be advanced a predetermineddistance into the passage 92 that is ascertainable and predictable. Thispredetermined distance may facilitate proper deployment of the clip 26with respect to the wall 98 of the vessel 90, e.g., to preventadvancement of the clip 26 too far, i.e., into the vessel 90.

Alternatively, or in addition, the splines 64 include radiopaquemarkers, such that fluoroscopy and the like may be used to monitor andposition the distal portion 60 of the locator member 14. The housing 24and/or closure element 26 may also include radiopaque markers such thata relative position of the closure element 26 with respect to thesplines 64, and consequently to the wall 98 of the vessel 90, may beascertained before the closure element 26 is deployed from the housing24.

In a preferred method, the splines 64 automatically return to theircollapsed configuration when the closure element 26 is deployed from thehousing 24 or when the housing 24 reaches its distal position, as shownin FIG. 4F. For example, the housing actuator assembly (not shown) maycontact the locator actuator (also not shown) when the housing actuatorassembly is used to advance the housing 24 to its distal position,thereby releasing the locator actuator. This enhancement may avoid anyrisk of contact between the clip 26 and the splines 64, e.g., whichotherwise may risk driving the barbs 28 of the clip 26 through the wall98 of the vessel 90 and into the splines 64. Alternatively, or inaddition, the distal portion 60 of the locator member 14 may beautomatically retracted, e.g., into the sheath 12, when the closureelement 26 is deployed or the housing 24 is advanced.

Once the clip 26 is successfully deployed within the passage 92, i.e.,into the wall 98 of the vessel 90, the apparatus 10 may be withdrawnfrom the passage 92. If the splines 64 of the locator member 14 are notautomatically collapsed during advancement of the housing 24, thesplines 64 may first be affirmatively collapsed, e.g., by depressing thelocator actuator (not shown). The entire apparatus 10 may then beremoved in one step, or alternatively, the locator member 14 may firstbe withdrawn from the sheath 12 before withdrawing the sheath 12,thereby leaving the clip 26 in place to close and/or seal the passage92.

Turning to FIGS. 7A and 7B, another embodiment of a distal portion 160of a locator member 114 is shown that may be used to position a sheath(not shown) before delivering a closure element (also not shown),similar to the embodiment described above. The locator member 114includes a flexible or semi-rigid tubular body 132 having a proximal end(not shown) and a distal end 136. An actuator wire or rod 138 isslidably disposed with respect to the body 132, e.g., within a lumen 133of body 132. The locator member 114 may include a detent (not shown) onor near its proximal end for securing the locator member 114 to a sheath(not shown).

The locator member 114 includes a distal portion 160 that terminates ina substantially rounded, soft, and/or flexible distal tip 162, possiblyincluding a pigtail (not shown) that may facilitate atraumaticadvancement of the distal portion 160 into a blood vessel or other bodylumen. The locator member 114 preferably has a length relative to thesheath such that the distal portion 160 extends beyond a distal end ofthe sheath when the locator member 114 is fully received in the sheath,similar to the embodiment described above.

A plurality of splines 164 are provided on the distal portion 160 thatmay be selectively expandable between a substantially collapsedconfiguration (shown in FIG. 7A) and a substantially transverse expandedconfiguration (shown in FIG. 7B). Preferably, the splines 164 aresubstantially rigid or semi-rigid elements that include hinged regions166, 168 that facilitate expansion substantially transversely withrespect to a longitudinal axis 113 of the locator member 114. In oneembodiment, each spline 164 is a single piece that includes a pluralityof living hinges 166, 168. Alternatively, each spline 164 may includemultiple segments that are connected by pins or other hinges (notshown). In a preferred embodiment, the distal portion 160 includes fourequally spaced splines 164, although the locator member 14 may includemore or fewer splines without deviating from the scope of the presentinvention. Optionally, the splines 164 may include radiopaque markers(not shown), similar to the embodiment described above.

Each spline 164 preferably has a first fixed end 164 a and a secondmovable end 164 b. The second end 164 b may be axially movable towardsthe first end 164 a to cause an intermediate region 164 c of the spline64 to expand transversely outward, thereby defining the substantiallytransverse expanded configuration. In a preferred embodiment, theactuator rod 138 extends through the distal portion 160 and is coupledto the second end 164 b of the splines 164 and/or to distal tip 162 ofthe locator member 114. The rod 138 may be moved axially with respect tothe body 132 to selectively expand the splines 164 between the collapsedand expanded configurations.

Turning to FIG. 8A, a locator actuator 170 may be coupled to the controlrod 138 and a proximal end 134 of the locator member 114. The locatoractuator 170 is configured for directing the control rod 138 axially toselectively expand the splines 164, similar to the embodiment describedabove.

In addition, the locator actuator 170 may allow the splines 164 to beexpanded to one of a plurality of expanded configurations. For example,the locator actuator 170 may include an internal member (not shown),coupled to the control rod 138, that is slidable within an actuator body176. A button 172 extending from the internal member is slidable in anaxial slot 174 in the actuator body 176 for controlling movement of thecontrol rod 138. The button 172 may be moved, thereby moving the controlrod 138 and consequently moving the splines 164. For example, as shownin FIG. 8A, the button 172 may be moved to a position (for example,indicated as “4”) thereby expanding the splines 164 to an expandeddiameter 165 a. If desired, the button 172 may be moved to otheravailable positions to reduce the expanded diameter, for example to thediameter 165 b shown in FIG. 8B. This control of the expanded diameterof the splines 164 may be useful to allow the splines 164 to be deployedwithin body lumens of different sizes. Thus, the splines 164 may beexpanded to a desired size corresponding to the size of the vessel intowhich the locator 114 is introduced, thereby minimizing the risk ofdamage to the vessel due to over expansion of the splines 164.

In an alternative embodiment, shown in FIG. 8B, the locator actuator170′ may include a rotatable dial that controls expansion of the splines164, similar to the linear actuator 170 shown in FIG. 8A. In addition,the locator actuator 170, 170′ may include demarcations indicating asize (not shown), e.g., a diameter of the expanded splines and/or thesize of the body lumen corresponding to the size of the lumen into whichthe locator 114 is to be introduced.

In a further alternative, shown in FIG. 9, a locator member 214 may beprovided that includes splines 264 that may be selectively expanded todifferent angles. A locator actuator (not shown) may allow controlledexpansion of the splines 264 a, 264 b to desired angles with respect tothe longitudinal axis 213 of the locator member. For example, a cable orother control wire (not shown) may be extended from the locator actuatorto each of the splines 264 a, 264 b, e.g., through a lumen (not shown)in the locator body 232. Each cable may be directed axially toselectively expand or collapse the spline 264 a, 264 b connected to therespective cable.

For example, a spline 264 b on the posterior side of the locator member214 (away from the surface of the patient's skin) may be expandedtowards the proximal end of the locator member 214 at an acute angle“alpha,” i.e., corresponding substantially to the angle of the passagethrough the patient's skin to the vessel 90, e.g., about thirty or fortyfive degrees. In contrast, the spline 264 a on the anterior side of thelocator member 214 (i.e. towards the surface of the patient's skin) maybe expanded away from the proximal end of the locator member 214 at anoblique angle of one hundred eighty degrees less “alpha.” Thus, thesplines 264 may be expanded to predetermined angles that facilitatebetter contact with the wall of the vessel, e.g., to better “present”the vessel wall during deployment of a closure element.

In yet another alternative embodiment, shown in FIG. 10, a locatormember 314, such as those described above, may include a tubular sleeve315 within which a body 332, including splines 364, may be axiallydirected. For example, a proximal end (not shown) of the sleeve 315 maybe fixed to a proximal end (also not shown) of the body 332, e.g., to alocator actuator (not shown), such as those described above. At least adistal portion 317 of the sleeve 315 is formed from a substantiallyrigid, smooth walled tube, such as a hypotube, while the remainder ofthe sleeve 315 may be a portion of the same tube or may be formed from asubstantially flexible or semi-rigid tubular member (not shown).

When the locator member 314 is fully inserted into an introducer sheath12, such as those described above, the distal portion 317 of the sleeve315 extends beyond a distal end 20 of the sheath 12. The splines 364 maythen be selectively deployed from within the sleeve 315, expanded to asubstantially transverse expanded configuration, collapsed, andretracted back into the sleeve 315.

For example, the sheath 20 may be positioned through a puncture 92 intoa vessel 90, e.g., to perform a procedure within a patient'svasculature, as described above. The locator member 314 may then beinserted into the sheath 12 until the distal portion 317 extends beyondthe distal end 20 of the sheath 12. The splines 364 may then beexpanded, and the sheath 12 and locator member 314 manipulated to adesired position, e.g., such that the splines 364 contact the wall 98 ofthe vessel 90, thereby providing a tactile indication of the position ofthe sheath 12.

A closure element, such as clip 26 may then be deployed, e.g., from ahousing (not shown) slidably mounted on the sheath 12. Barbs or tines 28on the clip 26 penetrate into the wall 98 of the vessel 90, e.g., toclose the opening in the wall 98 of the vessel 90, as described above.If the barbs 28 penetrate completely through the wall 98 of the vessel90, the sleeve 315 protects the splines 364 and/or the body 33 of thelocator member 314. The barbs 28 may engage but not penetrate orotherwise catch on the distal portion 317 of the sleeve 315, because ofits substantially rigid and/or smooth construction. Thus, the barbs 28may not penetrate or otherwise catch on the splines 364 when the clip 26is deployed. The splines 364 may be collapsed and retracted into thesleeve 315, either manually or automatically, similar to the embodimentsdescribed above. When the sheath 12 is withdrawn from the puncture 92,the barbs 28 may slide along the distal portion 317 of the sleeve 315until the distal portion 317 is withdrawn from within the clip 26,whereupon the barbs 28 may move inwards to close and/or seal the openingin the wall 98 of the vessel 90.

In alternative embodiments, the apparatus and methods of the presentinvention may be used to locate an introducer sheath within a bloodvessel and/or to deliver closure elements other than a clip. Forexample, the apparatus may be used to deliver a collagen plug and thelike into the passage, or a sealing material (either alone, or inconjunction with a clip).

Turning to FIGS. 11A-12B, another preferred embodiment of an apparatus410 is shown for sealing a passage through tissue communicating with abody lumen, such as a blood vessel, in accordance with the presentinvention. Generally, the apparatus 410 includes a plug member 412, anelongate shaft or handle device 414, and a locator member 416.

With particular reference to FIGS. 11A and 11B, the locator member 416includes a helically wound wire 444 that includes proximal and distalends 446, 448, defining a longitudinal axis 438 therebetween. Thehelically wound wire 444 may be formed from flexible material that isbiased to assume an axial configuration, as shown in FIG. 11A, but maybe deflectable, e.g., by buckling, as explained further below. Thehelically wound wire 444 has a diameter such that the locator member 416may be advanced through a lumen 440 of the handle device 414 (as shownin FIGS. 12A and 12B) and/or directly into a passage through tissue.Preferably, adjacent turns of the helically wound wire 444 are in closeproximity to or substantially abut one another in a relaxed state freefrom external forces, yet may be slidable and/or bendable with respectto one another to facilitate buckling of the locator member 416.Alternatively, adjacent turns of the helically wound wire 444 may havespaces between them in the relaxed state.

In a further alternative, the helically wound wire 444 may extend onlypartially from the distal end 448 towards the proximal end 446 (notshown). In this alternative, the locator member 416 may include asubstantially straight wire, tubular body, or other proximal portion(not shown) that may extend from the helically wound wire to theproximal end 446 of the locator member 416. The proximal portion may berelatively more rigid, e.g., resistant to buckling than the helicallywound wire and/or may be supported by the wall of the lumen 440 of thehandle device 414.

The locator member 416 also includes a tether or other control element450 that is coupled to the helically wound wire 444. Preferably, thetether 450 is an elongate wire, ribbon, cable, and the like that has adistal end 452 that is coupled to the distal end 448 of the helicallywound wire 444. The tether 450 may include a handle 456 on its proximalend 458 for selectively pulling the tether 450 in a proximal directionto cause the helically wound wire 444 wire to buckle, as explainedfurther below.

The tether 450 may extend along an outer surface of the helically woundwire 444 at least partially from the distal end 448 towards the proximalend 446, thereby defining a deflectable distal portion 454. For example,the tether 450 may extend along the outer surface of the helically woundwire 444 along its entire length. Alternatively, the tether 450 mayextend along the outer surface of the distal portion 454, and then maypass between turns of the helically wound wire 444, and extend withinthe helically wound wire 444 to the proximal end 446 of the locatormember 416. In a further alternative, the tether 450 may extend itsentire length within the helically wound wire 444. For example, if thehelically wound wire 444 has gaps between adjacent turns, the helicallywound wire 444 may be compressed when the tether 450 is pulled to causethe helically wound wire 444 to buckle.

An actuator (not shown) may be provided on the proximal end 446 of thelocator member 416. The actuator may be coupled to the proximal end 458of the tether 450 and to the helically wound wire 444 for providingcontrolled relative movement of the tether 450 and the helically woundwire 444, as will be appreciated by those skilled in the art.

When the proximal end of the tether 450 is in its distal-most position,the helically wound wire 444 may extend generally parallel to thelongitudinal axis 438, thereby defining an axial or inactivatedconfiguration, such as that shown in FIG. 11A. Even if the distalportion of the helically wound wire 448 becomes slightly curved, e.g.,when inserted into a body lumen, the distal portion is still considered“generally parallel” to the longitudinal axis 438. When the tether 450is directed proximally, e.g., by applying a proximal force on theproximal end 458 and/or handle 456, it may pull the distal end 448 ofthe helically would wire 444 towards the proximal end 446, therebycausing the distal portion 454 of the helically wound wire 444 tobuckle, thereby assuming a transverse or activated configuration, suchas that shown in FIG. 11B.

Turning to FIGS. 12A and 12B, the plug member 412 is a body, preferablyhaving a generally cylindrical shape, including a proximal end 420, adistal end 422, and an outer surface 430. The plug member 412 includes alumen 424 that extends between a proximal opening 426 and a distalopening or port 428. The plug member 412 may be formed frombiocompatible material, and preferably from bioabsorbable material,and/or may be substantially rigid or partially flexible.

The plug member 412 generally includes a helical thread pattern 418,including one or more helical threads, that extends at least partiallybetween its proximal and distal ends 420, 422. The helical threadpattern 418 is preferably substantially rigid and may have asubstantially square cross-section to facilitate sealing of a passageinto which the plug member 412 is threaded.

A sealing member (not shown) may be provided within the lumen 424 forsubstantially sealing the lumen 424 from fluid flow therethrough. Thesealing member is preferably formed from a material that expands whenexposed to fluids, e.g., a gel foam, and may be bioabsorbable, e.g., ifthe plug member 414 is. Before exposure to fluid, the sealing member maybe substantially recessed from the lumen 424, thereby accommodatinginserting devices therethrough. Upon exposure to fluid, e.g., blood, thesealing member may expand, e.g., due to hydration and the like, acrossthe lumen 424 and/or otherwise substantially seal the lumen 424.

Alternatively, the sealing member may be a valve (not shown) or a coilof material that is biased to substantially seal the lumen 424 fromfluid flow. For example, the sealing member may be biased tosubstantially seal the lumen 424, yet may be deflected to accommodateinsertion of one or more devices therethrough. In a further alternative,the lumen 424 may have a relatively small cross-section, and the sealingmember may be omitted.

Additional information regarding plug members appropriate for use withthe present invention may be found in U.S. Pat. No. 5,292,332 to Lee andU.S. Pat. No. 5,290,310 to Makower et al., the disclosures of which areexpressly incorporated herein by reference.

Returning to FIGS. 12A and 12B, the handle device 414 has a proximal end434, a distal end 436, and a lumen 440 that extends between the proximaland distal ends 434, 436, e.g., for accommodating insertion of thelocator member 416 and/or other devices therethrough. A handle 442 maybe provided on the proximal end 434 of the shaft 414 for facilitatingmanipulation of the apparatus 410, e.g., to facilitate rotation of theapparatus 410 into a passage, as described below. Preferably, the handledevice 414 is a substantially rigid tubular member having across-section that is substantially smaller than a cross-section of theplug member 412, e.g., to minimize dilation of a passage into which theplug member 412 is inserted.

The plug member 412 and the distal end 436 of the handle device 414generally include one or more connectors (not shown) for releasablysecuring the plug member 412 to the handle device 414, as described inapplication Ser. No. 09/732,835, filed Dec. 7, 2000, the disclosure ofwhich is expressly incorporated herein by reference. Preferably,cooperating connectors (not shown) substantially couple the plug member412 to the handle device 414 such that the plug member 412 cannot moveindependently of the handle device 414, e.g., such that the plug member412 may be rotated only by rotating the handle device 414. Preferably,the handle 442 includes an actuator (not shown) that may be activated torelease the connectors securing the plug member 412 to the handle device414.

When the locator member 416 is fully inserted into the handle device414, the distal portion 454 of the locator member 416, is preferablydisposed beyond the distal end 436 of the handle device 414, and, morepreferably, beyond the distal end 422 of the plug member 412, as shownin FIG. 12B. The locator member 416 may be coupled to the handle device414, e.g., by cooperating detents or other connectors on theirrespective proximal ends 446, 434. All of the distal portion 454 of thelocator member 416 may be disposed beyond the distal end 422 of the plugmember 412, or a portion of the distal portion 454 may extend into thelumen 424 of the plug member and/or the lumen 440 of the handle device414.

Turning to FIGS. 13A-13D, during use, the apparatus 410 may be used toseal and/or close a passage through tissue 96, such as a puncture 92communicating with a blood vessel 90 or other body lumen. Initially, theplug member 412 may be connected to or otherwise disposed on the handledevice 414. The locator device 416 may be inserted into the handledevice 414 until the distal portion 454 extends beyond the plug member412, as shown in FIG. 12B (but with the distal portion 454 in its axialconfiguration as shown in FIGS. 13A and 13B).

The puncture 92 may be used to provide percutaneous access to the vessel90. For example, the puncture 92 may facilitate performing anendovascular procedure within a patient's vasculature, such asangioplasty, stenting, atherectomy, and the like, or may otherwiseprovide access via the vessel 90 to a region within the patient's body.Upon completion of the procedure, any instruments, such as an introducersheath (not shown), may be removed from the vessel 90 and puncture 92.

The apparatus 410 may then be introduced into the puncture 92, forexample, by initially inserting the distal portion 454 of the locatormember 416 into the puncture 92. The distal portion 454 may have asubstantially atraumatic distal tip, e.g., tapered and/or relativelyflexible, to facilitate advancement of the apparatus 410 into thepuncture 92. As the distal portion 454 of the locator member 416 isadvanced into the puncture 92, the plug member 412 may be inserted intothe puncture 92, as shown in FIG. 13A.

Because of the thread pattern 418, the handle device 414 may be rotatedin a first direction to thread the plug member 412 into the puncture 92.Consequently, the outer surface 430 and/or the thread pattern 418 mayengage tissue 96 surrounding the puncture 92, thereby substantiallysealing the puncture 92 from fluid flow, such as blood flow, within thevessel 90. The apparatus 410 may be rotated in the first direction aboutits longitudinal axis 438 to thread the plug member 412 substantiallyatraumatically deeper into the puncture 92.

Turning to FIG. 13B, as the plug member 412 is advanced, the distalportion 454 of the locator device 416 eventually passes through the wall98 of the vessel 90. This advancement may be monitored by providing oneor more radiopaque markers (not shown) and the like on the handle device414, the plug member 412, and/or the locator member 416, and usingfluoroscopy while advancing the apparatus 410. Alternatively, depthmarkers (not shown) may be provided on the exterior of the handle device414 for visual monitoring advancement. Tactile indication, e.g.,resistance to further advancement, may also identify that the vessel 90has been attained.

Once it is confirmed that the distal portion 454 is located within thelumen 90, the locator member 416 may be activated, e.g., by pulling thehandle 456 proximally or activating an actuator (not shown) at theproximal end of the locator member 416. This causes the distal portion454 to buckle to its transverse configuration, as shown in FIG. 13C. Inthe transverse configuration, the distal portion 454 has a cross-sectionsuch that the distal portion 454 may not be withdrawn into the plugmember 412 and/or the puncture 92.

Rotation of the apparatus 410 may then be reversed, i.e., in a seconddirection opposite the first direction, to withdraw the plug member 412a predetermined distance relative to the vessel 90. As the plug member412 is withdrawn, the distal portion 454 of the locator member 416 mayengage a wall 98 of the vessel 90, thereby creating resistance tofurther rotation. This may provide tactile feedback that the plug member412 is disposed at a desired location, e.g., within the puncture 92 inclose proximity to the vessel 90, but not extended into the vessel 90.

The plug member 412 may then be released from the handle device 414. Thelocator member 416 may be deactivated, i.e., returned to its axialconfiguration, and then withdrawn from the plug member 412, eithersimultaneously withdrawal of the handle device 414 or before withdrawalof the handle device 414. The sealing member (not shown) preferablysubstantially seals the lumen 424 (not shown, see FIGS. 12A and 12B)within the plug member 412 to prevent fluid within the vessel 90 frompassing therethrough to leak from the puncture 92. Alternatively,leakage through the lumen 424 may be sufficiently insignificant, e.g.,hemostatis may occur rapidly despite the presence of the lumen 424, andthe sealing member may be eliminated.

Preferably, as explained above, the sealing member is a material thatexpands when exposed to fluid. For example, as the locator member 416 iswithdrawn (either before or along with the handle device 414), fluid,e.g., blood, may flow proximally through the lumen 424 in the plugmember 412, e.g., until it encounters the sealing member. Although arelatively small amount of fluid may pass beyond the sealing member, thesealing member may expand substantially due to the fluid contact untilit substantially seals the lumen. Alternatively, the sealing member maybe a valve that may open to accommodate the locator member 416, but mayautomatically close upon withdrawal of the locator member 416.

If the plug member 412 is bioabsorbable, it may remain within thepuncture 92 as the tissue heals, thereby allowing the wall 98 of thevessel 90 and tissue 96 surrounding the passage 92 to at least partiallyheal before the plug member 12 is absorbed. Alternatively, the plugmember 412 may be retrieved once the tissue between the plug member 12and the vessel 90 has substantially healed.

In an alternative embodiment, a guidewire 102 may be used during theprocedure. The apparatus 410 may be provided initially without thelocator member 416, and the guidewire 102 may be backloaded through theplug member 412 and handle device 414. The guidewire 102 may be used toguide the plug member 412 as it is threaded through the puncture 92until it at least partially enters the vessel 90. Once the vessel 90 hasbeen attained, the guidewire 102 may be withdrawn, and the locatormember 416 may be inserted through the handle device 414 until thedistal portion 454 extends beyond the plug member 412 into the vessel90. The distal portion 454 may be activated, and then the procedure mayproceed substantially as just described to deliver the plug member 412.

In a further alternative, the locator member 416 shown in FIGS. 11A and11B may be used to position and/or deliver other closure elements. Forexample, the locator member 416 may be substituted for the locatormember with expandable positioning elements shown and described above inconnection with FIGS. 1-3B, e.g., to deliver a clip within a housingthat is slidable along a sheath (not shown) through which the locatormember 416 may be inserted. In yet another alternative, the locatormember with expandable positioning elements shown and described above inconnection with FIGS. 1-3B may be used in place of the locator member416 to position and/or deliver the plug member 412, using methodssimilar to those described above.

Turning to FIGS. 15A-15D, an apparatus 410 may be used in conjunctionwith an introducer sheath 402 or other tubular member already in placewithin the passage 92. For example, the introducer sheath 402 may beused to access the vessel 90 to perform a procedure within the patient'svasculature or elsewhere within the patient's body, as described above.The sheath 402 may be disposed such that a proximal end 404 is locatedoutside the passage 92, and a distal end 406 is located within thevessel 90.

As shown in FIG. 15A, the locator member 416 may be inserted through theintroducer sheath 402 until the distal portion 454 extends beyond thedistal end 406 of the sheath 402 into the vessel 90. The distal portion454 may be buckled from the axial configuration to the transverseconfiguration, as described above, and then the locator member 416 maybe manipulated, e.g., pulled proximally, such that the buckled distalportion 454 engages or otherwise contacts a proximal wall 92 of thevessel 90. Thus, the locator member 416 may be secured from proximalmovement relative to the vessel 90 and/or may provide tactile feedbackof the location of the distal portion 416. The sheath 402 may be removedfrom the passage 92 either before or after buckling the distal portion454 of the locator member 416.

The plug member 412 may then be advanced over the locator 416 memberinto the passage 92. For example, the plug member 412, disposed on thedistal end 436 of an elongate member 414, may be threaded through thetissue 96 along the passage 92 such that threads 418 on the plug member412 substantially engage the surrounding tissue 96. The locator member416 may pass through a passage 424 in the plug member 412 and/or throughthe lumen 440 of the elongate member 414. Once the plug member 412reaches a desired location within the passage 92, the plug member 412may be released from the distal end 436 of the elongate member 414.

To facilitate positioning of the plug member 412 relative to the vessel90, the locator member 416 and/or the elongate member 414 may includeone or more depth markers. For example, the locator member 416 mayinclude a marker band 460 at a predetermined location relative to thedistal portion 454. The elongate member 414 may include a window 462 orother opening at a predetermined location on its proximal end 434. Whenthe marker band 460 on the locator member 416 appears in the window 462,it may provide a visual indication that the plug 412 is disposed at apredetermined position relative to the wall 98 of the vessel 90.Alternatively, the locator member 416 and the elongate member 414 mayinclude other cooperating elements, e.g., cooperating tactile elementsas described above, for identifying when the plug 412 is disposed at apredetermined location.

After the plug 412 is released from the elongate member 414, the distalportion 454 of the locator member 416 may be returned to its axialconfiguration, and the elongate member 414 and the locator member 416may be withdrawn from the passage 92, leaving the plug member 412 tosubstantially seal the passage 92, similar to the embodiments describedabove.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the appended claims.

What is claimed is:
 1. An apparatus for positioning a plug member withina passage through tissue communicating with a body lumen, comprising: anelongate member comprising a proximal end, a distal end, a lumenextending between the proximal and distal ends defining a longitudinalaxis, and an outer surface; a threaded plug member coupled to the distalend of the elongate member, a periphery of a proximal-most end of thethreaded plug member, at the coupling location of the threaded plugmember and the elongate member, being disposed radially outwardly beyondthe outer surface of the elongate member in both a pre-deployedconfiguration and a deployed configuration, the threaded plug membercomprising a distal port therein in communication with the lumen andconfigured for sealing the passage; and a locator member extending fromthe threaded plug member, the locator member comprising an elongatedeflectable element comprising a proximal end and a distal end, and acontrol element coupled to the distal end of the deflectable element,the control element being movable proximally for causing an intermediateportion of the deflectable element to transition from a first generallyaxial configuration to a second active configuration buckledsubstantially transversely with respect to the longitudinal axis.
 2. Theapparatus of claim 1, the thread pattern is on an outer surface of theplug member.
 3. The apparatus of claim 1, wherein the plug member isreleasable from the elongate member.
 4. The apparatus of claim 1,wherein the plug member comprises bioabsorbable material.
 5. Theapparatus of claim 1, wherein the deflectable element comprises ahelically wound wire extending between the proximal and distal ends ofthe deflectable element, and wherein the control element comprises atether extending along an outer surface of at least a portion of thehelically wound wire.
 6. The apparatus of claim 5, wherein theintermediate portion of the deflectable element has a cross-section inits buckled configuration that is larger than a cross-section of thedistal port.
 7. An apparatus for sealing a passage through tissuecommunicating with a body lumen, comprising: an elongate member having aproximal end, a distal end, a lumen extending between the proximal anddistal ends defining a longitudinal axis, and an outer surface; a plugmember coupled to the distal end of the elongate member, a periphery ofa proximal-most end of the plug member, at the coupling location of theplug member and the elongate member, being disposed radially outwardlybeyond the outer surface of the elongate member, the coupling of theplug and the elongate member exposing a proximal-most end of the plug tothe tissue in both a pre-deployed configuration and a deployedconfiguration, the plug member comprising a helical thread on its outersurface, the plug member comprising a distal port therein incommunication with the lumen; and a locator member extendable distallyfrom the distal port, the locator member comprising an elongatedeflectable element comprising a proximal end and a distal end, and acontrol element coupled to the distal end of the deflectable element,the elongate deflectable element including a helically wound memberhaving a proximal end spaced apart from a distal end in the longitudinalaxis, the distal end of the helically wound member being the distal endof the elongate deflectable element, the control element being movableproximally for causing an intermediate portion of the deflectableelement to buckle substantially transversely with respect to thelongitudinal axis from a first generally axial configuration to a secondsubstantially transversely buckled configuration.
 8. The apparatus ofclaim 7, wherein the deflectable element comprises a helically woundwire extending between the proximal and distal ends of the deflectableelement, and wherein the control element comprises a tether extendingalong an outer surface of at least a portion of the helically woundwire.
 9. The apparatus of claim 8, wherein the intermediate portion ofthe deflectable element has a cross-section in its buckled configurationthat is larger than a cross-section of the distal port.
 10. Theapparatus of claim 7, wherein the plug member comprises a passagetherein extending between the distal port and the lumen.
 11. Theapparatus of claim 7, wherein the plug member is releasable from theelongate member.
 12. The apparatus of claim 11, wherein the elongatemember comprises an actuator for releasing the plug member from thedistal end of the elongate member.
 13. The apparatus of claim 11,wherein the plug member comprises bioabsorbable material.
 14. Theapparatus of claim 7, wherein the locator member and the elongate membercomprise cooperating feedback elements for identifying when the locatormember is inserted a predetermined through the elongate member.